AIMOVIG SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ERENUMAB

Tersedia dari:

NOVARTIS PHARMACEUTICALS CANADA INC

Kode ATC:

N02CD01

INN (Nama Internasional):

ERENUMAB

Dosis:

70MG

Bentuk farmasi:

SOLUTION

Komposisi:

ERENUMAB 70MG

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

(1X1 ML) AND (2X1ML)

Jenis Resep:

Prescription

Area terapi:

CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0160530001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-08-01

Karakteristik produk

_AIMOVIG® (erenumab) _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AIMOVIG®
(erenumab injection)
Solution for Injection, 70 mg/mL, for subcutaneous use
Solution for Injection, 140 mg/mL, for subcutaneous use
Professed Standard
Anti-Calcitonin gene-related peptide receptor (anti-CGRPR)
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Initial Authorization:
August 01, 2018
Date of Revision:
October 27, 2022
Submission Control Number: 264464
® AIMOVIG & SureClick are registered trademarks of Amgen Inc. used
under license by
Novartis Pharmaceuticals Canada Inc.
_ _
_AIMOVIG® (erenumab) _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
7.0 WARNINGS AND PRECAUTIONS, Constipation with Serious
Complications
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.............